The Use of LIFUP in Chronic Disorders of Consciousness

Summary

When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.

Conditions

• Disorder of Consciousness
• Vegetative State
• Minimally Conscious State
• Minimally Conscious State Plus
• Minimally Conscious State Minus
• Traumatic Brain Injury
• CVA (Cerebrovascular Accident)
• Anoxia, Brain
• Thalamic Infarction
• Coma; Prolonged

Interventions

DEVICE

BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation

Administration of LIFUP will be performed at the bedside using frameless stereotaxy. Specifically, the LIFUP transducer will be fit to the patient's head employing adjustable straps, and will be positioned over the patient's left temporal bone, over the "temporal window" in order to minimize bone absorption and refraction. Accurate aiming will be ensured employing the BrainSight neuronavigation device, customized for tracking our LIFUP transducer (total \~10 min). Once satisfactory aiming is achieved, the LIFUP exposure will be initiated employing the settings described previously (which meet the FDA safety limits: ISPPA \<= 190W/cm2, ISPTA \<= 0.72W/cm2). Accurate aiming will be monitored in real-time throughout exposure using the Brain Sight Neuronavigation interface.

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• Tiny Blue Dot Foundation

  collaborator OTHER

• Casa Colina Hospital and Centers for Healthcare

  lead OTHER

Principal Investigators

• Caroline Schnakers, PhD · Casa Colina Hospital and Centers for Healthcare

• Martin Monti, PhD · University of California, Los Angeles

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-21

Primary Completion

2023-03-01

Completion

2023-04-14

FDA Device

Yes

Countries

• United States

Study Locations